Overview
The Medical Device Single Audit Program was developed by the International Medical Device Regulators Forum (IMDRF) to conduct regulatory audits of the quality management systems (QMS) used by manufacturers of medical devices.
The MDSAP audit is based on BS EN ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes - with the applicable regulatory requirements of the participating jurisdictions - Australia, Brazil, Canada, Japan and the USA - included as areas of focus. Audits conducted in accordance with the MDSAP follow a closely prescribed process of defined tasks. An MDSAP audit uses a process approach, based on a foundation of risk management, to select samples of procedures and records to examine. The audit focuses on how risks are identified and addressed.
This course will prepare you to host a MDSAP audit within your organisation, and allow you to determine if your own internal QMS processes are consistent with requirements of the MDSAP for the jurisdictions where your products are marketed, or for those markets which you are planning to access.
Recommended Reading
It is recommended that delegates have access to ISO 13485:2016 standard prior to attending the course.
CPD Hours: 12
Course Content
- Day 1
- Overview of MDSAP
- MDSAP audit approach
- Management process
- Device marketing authorisation and facilty registration
- Syndicate exercise - Management process
- Measurement, analysis and improvement
- Adverse events and advisory notice reporting
- Syndicate exercise - Measurement, analysis and improvement
- Q & A
- Day 2
- Introduction and recap of Day one
- Design and development
- Syndicate exercise - Design and development
- Production and service controls
- Syndicate exercise - Product and service controls process
- Purchasing
- Syndicate exercise - Purchasing
- Wrap up and Q & A
Speakers
Stuart Angell
Stuart Angell is a joint director in his own consultancy specialising in global regulatory affairs strategy and compliance for in vitro diagnostics and medical devices focusing on the transition to the new IVD/Medical Device Regulations, MDSAP and ISO13485:2016.
He has over 15 years in the IVD industry and in previous roles has been responsible for designing, reviewing and maintaining regulatory frameworks for self-declared and annex list II products including technical documentation for EU and global submissions (FDA, Health Canada, TGA, Russia, Latin America). He has an excellent understanding of risk management, Post Market Surveillance (PMS) and vigilance.
